Cassandra Ambuehl
Senior R&D Engineering Technician
St. Louis,MO
Even if you are on the right track, you’ll get run over if you just sit there.
Will Rodgers
Summary
An ever curious and driven technical problem solver that will fix problems and optimize any task at hand. With just over 10 years of experience in both the pharmaceutical and medical device industry utilizing scientific and engineering skills to improve and excel at any challenge. I am always eager to learn and master any skill, new or old.
Overview
10
10
years of professional experience
Work History
Senior R&D Engineering Technician - Compression
Cardinal Health
01.2022 - Current
- Facilitate testing and research for compression pumps, sleeves and compression stockings to ensure product functionality and proactively resolve any issues within the product
- Utilize DataMasters, temperature/sound chambers, Instron tensile testing, manometers, OGP microscopes, syringe pumps, leak testers, RF/ultrasonic welding, Magna-Mike, calipers and other scientific tools to execute all studies/testing
- Document data and R&D studies via laboratory notebooks and maintain GDP practices and adherence to government regulations for medical devices
- Write protocols for compression products and studies performed, confirming that all policies adhered to quality control/assurance standards and other best practices
- Train personnel to perform enteral feeding, thermometry, and compression testing on a wide variety of instruments/machines within R&D
- Organize physical and digital Design History Files (DHFs) and legacy file storage in compression DHF library, maintaining compliance with all quality control/assurance standards
- Supported Kendall SCD 700 tubing replacement on-site in Atlanta, GA for 2 weeks; ensuring pumps reached hundreds of customers after weeks of issue remediation
- Supported Kendall SCD SmartFlow software updates on-site in Hackensack, NJ; updated 500 pumps with new software and servicing two hospital sites in the area
- Supported Kendall SCD SmartFlow Implementation on-site in San Diego, CA; provided support and training for staffing and customer support sales for new product launch across two hospital sites in the area
R&D Engineering Technician II - Enteral Feeding & Thermometry
Cardinal Health
08.2018 - 01.2022
- Performed initial stability testing and other long form testing for Kangaroo OMNI Enteral Feeding pumps
- Tested Kangaroo Feeding Tube with IRIS Technology in long term studies involving the use of gastrointestinal fluid
- Tested legacy and in-development enteral feeding, thermometry and GI products by performing all product testing, requirements gathering and data analysis to provide product support
- Performed studies and research utilizing multimeters, flow rate devices, water baths, MTS tensile testing machines, testing/sound chambers, oscilloscopes, and other scientific instruments
- Documented study/test results and data within laboratory notebooks to ensure GDP and government regulation
- Supported a major reprogramming for Kangaroo Connect enteral feeding pumps in Atlanta, GA for 1 week; ensuring pumps reached hundreds of customers after the week of upgrades and issue remediation
Environmental Monitoring Technician
Patheon Biologics
10.2017 - 08.2018
- Oversaw all pharmaceutical areas at the site to determine and resolve the presence of adverse bacteria/mold in cGMP manufacturing areas (both environmental and water)
- Developed dozens of barcodes for daily sampling to design water and agar monitoring worklists, while maintaining accuracy and security of test tubes
- Maintained cGMP compliance with Environmental Monitoring SOPs, various clean room procedures, air monitoring equipment guidelines and contact plate/swabbing techniques
- Performed timely data analysis and entry within the MIMS database concerning mold and bacteria growth across agar rodac and settling plates
- Dressed in proper clean room attire appropriate for ISO5, ISO7 and ISO8 areas
- Cleaned and sanitized all monitoring and lab equipment via the autoclave
Buffers & Media Laboratory Technician
Patheon Biologics
08.2015 - 10.2017
- Created dozens of buffers and media formulations daily and promoted quality control and assurance for all workers and products involved in a cGMP production environment
- Weighed chemicals and performed testing to ensure quality buffers and media were formulated
- Facilitated scientific instrument and equipment calibration on pH and conductivity meters, turbidity meters, NOVA, and osmolality, complying with all SOPs and cGMP manufacturing procedures
- Trained personnel concerning cGMP manufacturing standards and policies, confirming that all personnel adhered to each policy in addition to promoting a highly organized 5S work environment in a clean room environment
- Dressed in proper clean room attire appropriate for ISO5, ISO7 and ISO8 areas
- Performed technical records management via upper-level SAP access as well as material consumption batch report generation
- Created shift notes at the conclusion of each workday and cGMP document evaluation and review to comply with cGMP standards
Education
Bachelor of Science - Environmental Science: Biology
05-2015
- Magna Cum Laude
- GPA: 3.81
Skills
- Scientific Testing & Test Methods, Data Management & Analysis, Personnel Oversight & Training, Technical Writing, Chemistry, Biology, Engineering, Regulatory Compliance, Protocol & Procedure Development, Research & Development, Laboratory Experience, Quality Control & Assurance, Information Security, Product & Project Management, Clinical Applications, Customer Support Sales, cGMP Documentation and Manufacturing, Equipment Operation & Calibration, Stability Studies, Environmental Monitoring, Pharmaceutical Manufacturing, Vehicle Manufacturing
- Cardinal Health Medical Products in Compression, Enteral Feeding and Thermometry, Buffers and Media Formulations, Chemical Formulations, Agile, Polarion, myLearning, DataMaster, Autoclave, Aseptic and Clean Room Techniques, Instron and MTS Tensile Testing, ISO5, ISO7, ISO8, pH Meters, Conductivity Meters, NOVA, OGP and Keyence Microscopes, Osmolality Meters, Turbidity Meters, Leak Testing, Flowmeters, Oscilloscopes, Manometers, Multimeters, Magna-Mike, RF/Ultrasonic Welding, Hipot, Microsoft Office, Six Sigma, 5S, SAP
Additional Experience
- Quality Engineering Intern | North American Lighting, Inc.
- Secretary to the Environmental Science Department | Southeast Missouri State University
- Environmental Science Intern | Inter-Rail Systems, Inc.
- Continuous Improvement Intern | North American Lighting, Inc.
Timeline
Senior R&D Engineering Technician - Compression - Cardinal Health
01.2022 - Current
R&D Engineering Technician II - Enteral Feeding & Thermometry - Cardinal Health
08.2018 - 01.2022
Environmental Monitoring Technician - Patheon Biologics
10.2017 - 08.2018
Buffers & Media Laboratory Technician - Patheon Biologics
08.2015 - 10.2017
Southeast Missouri State University - Bachelor of Science, Environmental Science: Biology
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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